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FEMSEVEN SEQUI

Active substance(s): ESTRADIOL HEMIHYDRATE / LEVONORGESTREL

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NT0FM20500XGB07
6507396 / 2630

PATIENT INFORMATION LEAFLET

FemSeven® Sequi 50 micrograms/10 micrograms/24 hours transdermal patch
(Estradiol/levonorgestrel)

Read all of this leaflet carefully before you start using
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist
- This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What FEMSEVEN SEQUI®, PATCH is and what it is used
for
2. Before you use FEMSEVEN SEQUI ®, PATCH
3. How to use FEMSEVEN SEQUI ®, PATCH
4. Possible side effects
5. How to store FEMSEVEN SEQUI®, PATCH
6. Further information

2. BEFORE YOU USE FEMSEVEN SEQUI®, PATCH
You should fully inform your doctor about your personal
medical history and that of your immediate family, before
starting with hormone replacement therapy (HRT)
Medical examinations and tests
Your doctor will ask you to undergo a medical
examination before beginning treatment then regularly
during the treatment (at least once a year) to check
whether your body is tolerating the medication.
Your breasts will be regularly examined by your doctor,
especially if you have any lumps (cysts or nodules) or if
anybody in your family has already had breast cancer.
Your doctor may ask you to have a mammography.
From time to time, at least once a year, the risks and
benefits of HRT treatment should be carefully reassessed
to determine if the treatment should be continued.
Do not use FEMSEVEN SEQUI®, PATCH
- if you are allergic (hypersensitive) to one of the active
substances (Estradiol or Levonorgestrel) or any of the
other ingredients of FEMSEVEN SEQUI® (see also section
6).
- If you have, have had or your doctor thinks you might
have breast cancer.
- if you have previously had a blockage of one of your
veins in your leg or lungs (deep venous thrombosis or
lung embolism), or if you currently have such a blockage
- if you have thrombophilic disorders (e.g. protein C,
protein S, or anthithrombin deficiency)
- if you currently have or have recently had a blockage of
an artery, for example, angina pectoris (heart cramp due
to an oxygen deficiency) a heart attack or stroke
- If you have, or your doctor thinks you might have,
breast, uterine or any other cancer requiring a hormone
to develop (oestrogen-dependent cancer).
- If there is excessive proliferation of cells in the inner
lining (endometrial hyperplasia) that has not been treated
yet.
- If you experience unexplained vaginal bleeds.
- If you currently have or have previously had a liver
disorder. You must not use FEMSEVEN SEQUI® for as long
as the liver function has not returned to normal
- If you have a (herediatary) disorder in the composition
of the blood pigment (porphyria).

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Take special care with FEMSEVEN SEQUI®, PATCH
Tell your doctor if you have or have previously had any of
the following disorders and/or if these conditions have
been aggravated during pregnancy or previous hormone
therapy, before you start using FEMSEVEN SEQUI®.
- If you have high blood pressure,
- If you have an increased risk of developing blood clots
(see “HRT and effects on heart or blood circulation”),
- If you have a high blood sugar level (diabetes) with or
without vascular disorders
- If you have a disease leading to the presence of uterine
mucosa outside your uterus causing pain and bleeding
(endometriosis),
- If you have a benign tumour in your uterus (uterine
fibroma),
- If you have a history of excessive proliferation of cells in
the inner lining (endometrial hyperplasia),
- If you have an increased risk of developing tumours
related to the levels of oestrogens in the blood (such as
having a close relative with breast cancer)
- If you have liver or gallbladder disease (hepatic
adenoma, gallstones),
- If you suffer from epilepsy,
- If you have severe headaches or migraines,
- If you have asthma,
- If you have a serious immune disease that affects your
skin in particular (lupus),
- If you have a disease causing loss of hearing
(otosclerosis).

Stop using FEMSEVEN SEQUI® immediately
If you experience any of the disorders mentioned under
“Do not use FEMSEVEN SEQUI®, PATCH”, or if any of the
following situations occurs:
- you experience a yellowing of the skin (jaundice) or your
liver function deteriorates;
- your blood pressure suddenly becomes much higher;
- you get a migraine-like headache for the first time;
- you become pregnant.
Note: FEMSEVEN SEQUI® is not a transdermal
contraceptive and does not prevent you from becoming
pregnant.
You must also inform your doctor if:
- You are to undergo surgery.
- You have to remain immobilised for a long period.
- You have contracted another disease.
What risks are associated with the use of FEMSEVEN
SEQUI® PATCH?
HRT and effects on heart or blood circulation
Blood clots (thrombosis):
Immediately inform your doctor if you have painful
swelling of one of your legs, sudden pain in the
chest, or shortness of breath while using
FEMSEVEN SEQUI® PATCH. This could be a sign of
venous thrombosis or a lung embolism while, in
which case you must stop using FEMSEVEN
SEQUI® PATCH immediately.
HRT increases the risk of VTE 1.3-3 fold, especially during
the first year of taking it.

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1. WHAT FEMSEVEN SEQUI®, PATCH IS AND WHAT
IT IS USED FOR
FEMSEVEN SEQUI® is a sequential combined Hormone
Replacement Therapy (HRT). It contains an oestrogen
(estradiol) and a progestogen (levonorgestrel). FEMSEVEN
SEQUI® is suitable for postmenopausal women.
During the menopause, the amount of oestrogen
produced by a woman’s body drops. For some women
this can cause symptoms such as hot face, neck and chest
("hot flushes"). FEMSEVEN SEQUI® alleviates these
symptoms after menopause.
The experience treating women above the age of 65 is
limited.

Compare
Looking at women in their 50s who are not taking HRT,
on average, over a 5-year period, 4 in 1000 would be
expected to get a blood clot.
For women in their 50s who are taking HRT over 5 years,
the number of extra cases will be 5 in 1000 users.
The risk of venous thrombosis is greater:
• If you use oestrogens;
• With older age;
• If you have a cancer;
• During pregnancy and postpartum period;
• If there is venous thrombosis in your immediate family;
• If you are severely overweight
• If you have systemic lupus erythematosus (a disorder of
the immune system);
• If you have any blood clotting problem that needs longterm treatment with a medicine used to prevent blood
clots
• If you are immobilised for long periods (e.g. when you
must have bed rest), have an accident or a major surgery.
In these circumstances it might be necessary for you to
stop using FEMSEVEN SEQUI® PATCH temporarily. You
may need to stop as early 4-6 weeks before planned
surgery.
It is unclear whether having varicose veins leads to an
increased risk of venous thrombosis.
If any of these situations apply to you, please inform your
doctor. If you are using an anticoagulant, the risks and
benefits of using HRT have to be carefully evaluated.
Disorders of the coronary arteries:
Stop using FEMSEVEN SEQUI® PATCH and contact
your doctor immediately, if you get a pain in your
chest that spreads to your arm or neck. The pain may
be a sign of a heart disease.
There is no evidence that HRT will help to prevent heart
disease. Women taking oestrogen-progestogen HRT are
slightly more likely to get heart disease than those not
taking any HRT. As the risk of CAD strongly depends on
age, the number of extra cases of CAD due to oestrogenprogestogen use is very low in healthy women close to
menopause, but will rise with more advanced age.
Risk of stroke:
Stop using FEMSEVEN SEQUI® PATCH and contact your
doctor immediately if you get: unexplained migraine-like
headaches, with or without disturbed vision. Such
headaches can be an early sign of a stroke.
Combined oestrogen-progestogen and oestrogen-only
HRT increase the risk of stroke up to 1.5-fold. The risk of
users compared to non-users does not change with age
or time since menopause. However, as the risk of stroke is
strongly age-dependent, the overall risk of stroke in
women who use HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT,
on average, over a 5-year period, 8 in 1000 would be
expected to have a stroke.
For women in their 50s who are taking HRT over 5 years,
the number of extra cases will be 3 in 1000 users.
HRT and risks of developing cancer
Overgrowth of the lining of the womb (endometrial
hyperplasia) and cancer of the womb lining (endometrial
cancer).
Long-term use of estrogen increases the risk of
overgrowth of the lining of the womb (endometrial
hyperplasis) and the risk of endometrial cancer in women
with an uterus. To reduce this risk it is necessary to take
the estrogens in combination with progestogen tablets
for at least 12 days of each month.
During the first months of treatment irregular bleeding
may occur. Contact your doctor if
- such bleeding carries on for more that the first few
months of treatment
- starts after you have been on FEMSEVEN SEQUI® PATCH
for a while
- carries on even after you have stopped using FEMSEVEN
SEQUI® PATCH
Your doctor will examine what the cause is which may
include a biopsy of the womb lining in order to find out
whether you have cancer of the womb lining.
Compare
Looking at women who still have a womb and who are
not taking HRT, on average 5 in 1000 will be diagnosed
with endometrial cancer.
For women who take oestrogen-only HRT, the number of
extra-cases will be between 5 and 55 in 1000 users
between the ages of 50 and 65 depending on the dose
and for how long it is taken.
The addition of a progestogen to oestrogen-only HRT
substantially reduces the risk of endometrial cancer.
Breast cancer:
Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. This depends on how
long you take HRT, and the extra risk is visible after about
3 years. However, it returns to normal within a few (at
most five) years after stopping.
Contact your doctor if you notice changes to your
breasts, such as: dimpling of the breast, skin changes in
the nipple, lumps that you can see or feel.
Your doctor may advice you to undergo a check up
including mammography.
Compare
Looking at women aged 50 to 65 who are not taking HRT,
on average 9-12 in 1000 will be diagnosed with breast
cancer over a 5 year period.
For women aged 50-65 who are taking oestrogen plus
progestogen HRT over 5 years the number of extra-cases
will be 6 in 1000 users.
Looking at women aged 50 to 79 who are not taking HRT,
on average 14 in 1000 will be diagnosed with breast
cancer over a 5 year period.
For women aged 50-79 who are taking oestrogen plus
progestogen HRT over 5 years the number of extra cases
will be 4 in 1000 users.
Ovarian cancer:
Ovarian cancer is much rarer than breast cancer. Longterm (at least 5-10 years) use of oestrogen-only HRT
products is thought to carry a slightly increased risk of
ovarian cancer. Some studies suggest that the long-term
use of combined HRTs may carry a similar, or slightly
smaller, risk. For women who are taking HRT over 5 years
there will be one extra case per 2500 users.
HRT and other disorders:
• If you suffer from cardiac or kidney dysfunction you
will have to be monitored while using FEMSEVEN SEQUI®
PATCH
• If you have very high triglyceride levels in your blood
(hypertriglyceridaemia) you will have to be monitored
when using FEMSEVEN SEQUI® PATCH.
HRT will not improve thought processes. There are hints
of an increased risk of probable dementia in women who
start using HRT after the age of 65.
Consult your doctor if one of the above-mentioned
warnings should apply to you, or if it has previously
applied to you.
Taking or using other medicines
Some medications can alter the effectiveness of
FEMSEVEN SEQUI® in particular if you are taking:
- a medicine to treat epilepsy (carbamazepin,
phenobarbital, phenytoin),
- a medicine to treat tuberculosis or other infectious
diseases (rifampicin, rifabutin),
- a medicine to treat AIDS (ritonavir, nelfinavir, nevirapine,
efavirenz),

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- a medicine containing St. John’s Wort (Hypericum
perforatum).
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not use FEMSEVEN SEQUI® if you are
pregnant or breastfeeding.
If you discover that you are pregnant while using this
medication, stop the treatment and discuss the situation
with your doctor.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
No specific side effect is expected.

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How to remove the patch?
To remove a FEMSEVEN SEQUI®, simply free up one edge
and pull it off gently so as not to irritate the skin. If any
of the adhesive remains on the skin, you can remove it by
rubbing the skin gently with a cream or an oily lotion.
After use, the patch still contains active substances, but
in too small a quantity for it to remain effective. Fold the
patch in half (adhesive to adhesive) before discarding it.
Precautions for use
Do not apply a FEMSEVEN SEQUI® PATCH:
- to your breasts.
- Twice in the same place: leave at least 1 week between
2 applications in the same place.
During the course of treatment:
- You must not expose the patch directly to the sun once
you have applied it to your skin.
- You can shower or take a bath with the patch on your
skin.
- If the patch becomes unstuck before the end of its use
i.e. before the 7th day (for example if you have
undertaken intense physical effort or perspire abundantly
or the skin is rubbed by clothes), use a new patch (from
the same phase) and remove it at the initially scheduled
date.
Duration of treatment
Your doctor will decide on the duration of treatment.
Contact your doctor if you want to stop the treatment.
If you take more FEMSEVEN SEQUI® than you should
Overdose is unlikely but it can cause the following:
- pain in the breasts,
- bloating in the abdomen, flatulence, nausea and
vomiting,
- irritability, anxiety,
- vaginal bleeding.
No specific treatment is required. The signs will disappear
when the patch is removed.
If you forget to take FEMSEVEN SEQUI®, PATCH
- If you have forgotten to change the patch on the
scheduled day, replace it immediately then follow the
treatment normally, changing the patch again on the
initially scheduled day.
- Do not use 2 patches at the same time to make up for
the single dose that you have forgotten.
- If you have not used FEMSEVEN SEQUI ® for several
successive days, you may get stop bleeding. If you are in
doubt, consult your doctor.
If you stop using FEMSEVEN SEQUI®, PATCH
The postmenopausal signs linked to a lack of oestrogen
may reappear.

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3. HOW TO USE FEMSEVEN SEQUI®, PATCH
Always use FEMSEVEN SEQUI® exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
You should apply the patch once a week i.e. replace it
every 7 days without a break in treatment: as soon as you
remove one patch, you should apply another one to your
skin.
There are 2 types of patches in the box, depending on
when you apply one:
- Phase 1 patches (1st and 2nd weeks of your cycle): they
contain only one active substance (Estradiol).
- Phase 2 patches (3rd and 4th weeks of your cycle): they
contain both active substances (Estradiol and
Levonorgestrel).
If you are not taking HRT or you switch from a
continuous combined HRT product, treatment may be
started on any convenient day.
If you are transferring from a sequential HRT regimen,
treatment should begin the day following completion of
the prior regimen.
Frequency of application:
1. Apply a Phase 1 patch once a week for the first 2 weeks
of your cycle.
2. Remove the Phase 1 patch and apply a Phase 2 patch
in its place, once a week for the following 2 weeks.
You must apply the patches in the correct order.
Bleeding similar to periods usually occurs at the end of
the use of the Phase 2 patches. The bleeding is light and
lasts for 4 to 5 days on average.
If the bleeding is heavy or irregular, consult your doctor.
Method of administration
This medicine should be applied to the skin.
How to apply a patch?
Each sachet contains one patch.
FEMSEVEN SEQUI® must be applied immediately after
being removed from its sachet.
1. To open the sachet, tear the two edges in the direction
of the arrow.
2. Remove the patch from the sachet. A patch has two
sections: the patch itself, which must be applied to the
skin, and the protective liner.
3. Remove one-half of the liner, starting at the S-shaped
notch and taking care not to touch the adhesive side of
the patch with your fingers. If you do, it may not adhere
correctly and you may alter the active ingredients.
4. Apply the patch immediately, using the palm of your
hand, to a dry, clean area of skin. It should not be red or
covered with cream or lotion. The location should not
have any significant wrinkles and it should not be rubbed
by clothing (avoid placing at the waist and do not wear
very tight clothing). The patch may be applied, for
example, to the buttocks, thighs, abdomen etc.
5. Remove the other part of the plastic liner and press
down on the corresponding area of the patch.
6. Keep the palm of your hand on the patch for at least
30 seconds to ensure that it is adhering correctly,
especially round the edges. The pressure and heat of the
hand are essential to ensure maximum adhesion.

If you have any further questions, ask your doctor or your
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FEMSEVEN SEQUI® can cause side
effects, although not everybody gets them.
The following side effects may occur the most
frequently (in more than 1 in 10 patients treated).
- Skin reaction (itching, irritation, redness) in the area in
which the patch is applied. These signs are not serious
and usually disappear 2 or 3 days after removing the
patch. If they persist, place the patch in a different area.
The following side effects may occur frequently (in
1 to 10 people in 100):
- Tightness or pain in the breasts.
- Headaches.
- Nausea, vomiting.
- Irregular bleeding, spotting
- Increase or decrease in sexual desire.
The following potential side effects are less frequent
(in 1 to 10 people in 1,000):
- Benign breast tumour.
- Painful periods.
- Abnormal development of the lining of the uterus
(endometrial hyperplasia).
- High blood pressure.
- Bloating or pain in the abdomen.
- Fatigue.
- Weight gain or loss.
- Migraine.
- Vertigo.
- Cramp in the legs.
- Swelling (water retention, oedema).
The following side effects may occur but are rare
(1 to 10 people in 10,000):
- Yellowing of the skin and whites of the eye (jaundice).
- Benign tumour in the uterus (uterine fibroma).
- Gall stones
- Depression.
The following side effects can also occur:
- Breast cancer or uterine (endometrial) cancer.
- Formation of a blood clot in a vein in the leg (phlebitis)
or lungs (pulmonary embolus).
- Formation of a blood clot in brain (stroke) or heart
(heart attack).
- Gallbladder problems.
- Mental disorders (dementia).
- Disorders of the skin, or subcutaneous disorders such
as:
• Formation of brown spots on the face after exposure to
sunlight, also referred to as a mask of pregnancy
(chloasma).
• Skin disease with spots in the form of red marks and
blisters filled with liquid (erythema multiforme).
- Skin disease with the formation of lumps under the skin
that are red and painful (erythema nodosum).
• Minor skin bleeds (Henoch-Schönlein purpura).
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE FEMSEVEN SEQUI®, PATCH
Keep out of the reach and sight of children.
Do not use a FEMSEVEN SEQUI® PATCH after the expiry
date which is stated on the box. The expiry date refers to
the last day of that month.
Store below 30°C.
Do not use a FEMSEVEN SEQUI® PATCH if you notice any
visible signs of deterioration of the patch.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What FEMSEVEN SEQUI®, PATCH contains
• The active substances are:
- Phase 1 patch: Estradiol hemihydrate (1.50 mg) for 15
cm2 patch providing 50 micrograms Estradiol every 24
hours.
- Phase 2 patch: Estradiol hemihydrate (1.50 mg) and
Levonorgestrel (1.50 mg) for 15 cm2 patch providing 50
micrograms Estradiol and 10 micrograms Levonorgestrel
every 24 hours.
• The other ingredients are:
- Liner: transparent polyethylene terephtalate (PET) film.
- Adhesive component: styrene-isoprene-styrene
copolymer beads, glycerin esters of totally hydrogenated
resin acids.
- Backing: silicon-coated transparent polyethylene
terephtalate (PET) film.
What FEMSEVEN SEQUI®, PATCH looks like and
contents of the pack
The product is a transparent, flexible, octagonal patch
with rounded edges. The backing is larger and detachable.
Each box contains 4 patches (2 Phase 1 patches and 2
Phase 2 patches) or 12 patches (6 Phase 1 patches and 6
Phase 2 patches), each individually wrapped.
Not all box sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG.
Manufacturer :
LABORATOIRE THERAMEX
6, avenue Albert II, 98000 Monaco, MONACO
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany, Luxemburg:
FEM7 COMBI® 50 microgams/10 micrograms/24 hours,
transdermal patch
Austria, Finland:
FEMSEVENCOMBI® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
Belgium:
FEMINOVA PLUS® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
Spain:
COMBIFEM® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
France:
FEMSEPTCOMBI® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
United Kingdom:
FEMSEVEN SEQUI® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
Italy:
COMBISEVEN® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
Netherlands:
FEM7 SEQUI® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
Portugal:
FEMSETE COMBI® 50 microgams/10 micrograms/24 hours,
dispositif transdermique
This leaflet was last approved in 12/2012.

NT0FM20500XGB07
6507396 / 2630

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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